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A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

NCT01870739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2021-01-05

Study results available
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Summary

This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.

Conditions

Interventions

DRUG

sacubitril/valsartan (LCZ696)

200 mg tablets

DRUG

olmesartan

OTHER

placebo to sacubitril/valsartan (LCZ696)

placebo

OTHER

placebo to olmesartan

placebo

DRUG

Amlodipine (Optional)

If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Germany
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01870739 on ClinicalTrials.gov